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HPRA recommendation could lead to ‘severe maternal morbidity’ – IMPS

Implementing a recommendation approved by the Health Products Regulatory Authority (HPRA) could lead to “sub-optimal control” of hyperemesis gravidarum (HG) and “potentially severe maternal morbidity”, according to the Irish Medicines in Pregnancy Service (IMPS).

The IMPS, based at the Rotunda Hospital, noted that in late 2019 the marketing authorisation holders (MAH) for ondansetron (Zofran) wrote to healthcare professionals regarding its safety during the first trimester of pregnancy.

The communication followed recommendations from the European Medicines Agency (EMA) and HPRA, which included that ondansetron should not be used during the first trimester. This recommendation applied to ondansetron’s licensed indications, which does not include HG, noted the IMPS.

HG is a complication of pregnancy characterised by severe, protracted nausea and vomiting. In its position statement, the IMPS recommended that ondansetron should remain a treatment option for women with HG, where first-line agents have not been effective. Women should be adequately counselled on benefits and potential risks.

The IMPS did not consider that available data supported the conclusion that ondansetron caused congenital anomalies.

An IMPS spokesperson said its statement offered “pragmatic recommendations from the perspective of healthcare professionals”. A HPRA spokesperson said the EMA’s safety committee examined ondansetron in its licensed uses. This followed a review of new safety data, which reported “a small but increased risk” of orofacial malformations linked to the drug’s use in the first trimester.

As ondansetron is not licensed for use in HG in the EU, the EMA committee did not conduct a benefit-risk assessment in this off-label indication.

Off-label use was a matter of clinical judgement and prescribers “can refer to clinical guidelines” if treatment with ondansetron is considered for HG, stated the HPRA spokesperson. The HPRA “fully agrees with the principle that the risks to the unborn child when taking a medicine during pregnancy have to be weighed against the risks to the mother and child of not taking the medicine”.

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